ISAC Documentation and Record Keeping 4

Question 1

What is the role of a Laboratory Information System (LIS) in flow cytometry documentation?

Accepted Answer

It centralizes patient ordering, result entry, and audit trails for traceability

Answer

An LIS integrates specimen ordering, result entry, and audit trails into a centralized system that supports traceability and regulatory compliance.

Question 2

Which term describes the documented process of verifying that a flow cytometry assay performs as intended in a specific laboratory before patient testing begins?

Accepted Answer

Method validation

Answer

Method validation is the documented process confirming that an assay meets defined performance criteria (accuracy, precision, reference range) in that specific lab.

Question 3

In flow cytometry documentation, what is the purpose of recording the instrument serial number in every run log?

Accepted Answer

It links results to the specific instrument, enabling traceability if an instrument is found to have malfunctioned

Answer

Recording the instrument serial number allows all results from a malfunctioning instrument to be identified and investigated without ambiguity.

Question 4

When training a new flow cytometry operator, which documentation must be completed before the trainee can independently report patient results?

Accepted Answer

Competency checklist demonstrating they can perform the assay, interpret results, and troubleshoot, signed by the supervisor

Answer

A competency checklist signed by the supervisor is required to formally document that the trainee has demonstrated the skills necessary for independent testing.

Question 5

Which of the following best describes a 'delta check' in flow cytometry result documentation?

Accepted Answer

A comparison of a patient's current result to a previous result to flag unexpected changes

Answer

A delta check compares current patient results to previous results to identify unexpected changes that may indicate sample mislabeling or patient status change.

(ISAC) International Society for the Advancement of Cytometry Practice Test

(ISAC) International Society for the Advancement of Cytometry Practice Test

ISAC Documentation and Record Keeping 4